Evaluation of the Severity of Hepatic Fibrosis by Magnetic Resonance Elastography in the Diagnosis of Endogenous Hypercorticism

Not Applicable

Recruiting

• Conditions: Cushing Syndrome; Metabolic Syndrome
• Interventions: Device: Magnetic resonance elastography (MRE)

• Registration Number: NCT05911620
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The main hypothesis of the HEPACORT study is that upon diagnosis of endogenous Cushing's syndrome, significant liver fibrosis may be present, particularly in the most severe forms of Cushing's syndrome.

the HEPACORT study is the first exploratory study to assess the severity of liver fibrosis in patients with Cushing's syndrome or suspected of presenting by Magnetic Resonance Elastography (MRE).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-02
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-22
• Status Verified: 2023-10
• Study Start: 2023-10-24
• Last Update Submitted: 2023-10-24
• Last Update Posted: 2023-10-25
• Primary Completion: 2026-02-28
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• age ≥ 18 years old;
• Person affiliated to a social security scheme or beneficiary of such a scheme;
• Person having received complete information on the organization of the research and having signed informed consent;
• Person having carried out a preliminary clinical examination adapted to the research.
• Patients with Cushing's syndrome (for the Cushing's Syndrome group)
• Patients with possible Cushing's syndrome (for the suspected Cushing's Syndrome group) defined as response to the dexamethasone supression test with 1 mg of Dexamethasone, with a plasma cortisol assay at 8 am between 18 and 50 µg/L carried out in the 3 months preceding ;
• Patients with metabolic syndrome (for the metabolic syndrome group)

Exclusion Criteria

• Person having taken corticosteroid therapy for more than 3 months during the 2 years preceding inclusion;
• Person having received corticosteroid therapy of shorter duration with discontinuation less than one month before inclusion;
• Person having taken anticortisolic treatment for more than 3 months during the 2 years preceding inclusion;
• Person with chronic liver disease;
• Person with alcohol misuse, defined by a weekly consumption of more than 10 standard units;
• Person with a morphotype that does not allow an MRI examination to be performed;
• Woman of childbearing age who does not have an effective means of contraception;
• Contraindication to performing an MRI examination.
• Person referred to in Articles L. 1121-5, L. 1121-7 and L1121-8 of the French Public Health Code.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Metabolic Syndrome	Magnetic resonance elastography (MRE)	Patients with metabolic syndrome
Cushing's Syndrome	Magnetic resonance elastography (MRE)	Patients with proven autonomic cortisol secretion (Cushing's Syndrome)
Suspected Cushing's Syndrome	Magnetic resonance elastography (MRE)	Patients with possible autonomic cortisol secretion (Suspected Cushing's Syndrome)

Primary Outcome Measures

Name	Time	Method
Estimation of the severity of hepatic fibrosis by MRE (kPa).	Baseline (day 0)	Estimation of the severity of hepatic fibrosis in kPa by a non-invasive elastography method : magnetic resonance elastography.

Secondary Outcome Measures

Name	Time	Method
Evolution of transaminases (UI/L) between the diagnosis and the last visit.	1 year
Evaluation of the association between osteoporosis (g/cm²) with the presence of Fibrosis by MRE (kPa).	Baseline (day 0)
Evaluation of the association between high blood pressure (mmHg) with the presence of Fibrosis by MRE (kPa).	Baseline (day 0)
Evaluation of the association between overweight (kg) with the presence of Fibrosis by MRE (kPa).	Baseline (day 0)
Evaluation of the presence of hepatic fibrosis by MRE (kPa).	Baseline (day 0)	Evaluation of the presence of hepatic fibrosis by ERM : ERM value ≥ 72.5 kPa.
Evolution of Bilirubin (mg/L) between the diagnosis and the last visit.	1 year
Evolution of platelets (platelets/mm3) between the diagnosis and the last visit.	1 year
Evolution of Albumin (g/L) between the diagnosis and the last visit.	1 year
Evaluation of the association between hyperglycemia (blood glucose by g/L) with the presence of Fibrosis by MRE (kPa).	Baseline (day 0)
Evolution of GGT (gamma-glutamyl transferase) (UI/L) between the diagnosis and the last visit.	1 year
Evolution of ALP (Alkaline Phosphatases) (UI/L) between the diagnosis and the last visit	1 year
Evolution of ferritin (ng/mL) between the diagnosis and the last visit.	1 year

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France